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Completed

NCT Number: NCT00221104

Japan Statin Treatment Against Recurrent Stroke (J-STARS)

Although hyperlipidemia is not always the risk factor of stroke, inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can decrease the incidence of stroke in the patient with ischemic heart disease. The neuroprotective mechanism beyond cholesterol lowering should be expected to attenuate inflammation and atherosclerosis. The present study hypothesizes if pravastatin prevents recurrent stroke in the ischemic stroke patients with safety.

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Key information

Conditions

Ischemic Stroke Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Disease Attributes Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Stroke Vascular Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hiroshima University

Hiroshima, 734-8551, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ischemic stroke except for cardiogenic embolism, from 1 month to 3 years after onset
  • Hyperlipidemia and total cholesterol level of 180-240mg/dl without the prescription of statin within previous 30 days
  • Able to visit outpatient department
  • Informed consent on the form.

Exclusion criteria

  • Ischemic stroke of other determined cause according to the TOAST classification
  • Ischemic heart disease and necessary to use statin
  • Hemorrhagic disorders
  • Platelet count <=100,000/ul within 3 months prior to study start
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>= 100IU/L within 3 months prior to study start
  • Serum creatinine >=2.0mg/dl within 3 months prior to study start
  • A scheduled operation
  • The presence of malignant disorder

Treatment and study plan

Pravastatin

Drug

Primary outcomes

  1. Incidence Rate of Stroke and TIA

    Time frame: up to 5 years

    Incidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA)

Secondary outcomes

  1. Incidence Rate of Atherothrombotic Infarction

    Time frame: up to 5 years

    Incidence rate of patients with atherothrombotic infarction

  2. Incidence Rate of Lacunar Infarction

    Time frame: up to 5 years

    Incidence rate of patients with lacunar infarction

  3. Incidence Rate of Cardioembolic Infarction

    Time frame: up to 5 years

    Incidence rate of patients with cardioembolic infarction

  4. Incidence Rate of Intracranial Hemorrhage

    Time frame: up to 5 years

    Incidence rate of patients with intracranial hemorrhage

Sponsors and collaborators

Lead sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Other

Collaborators

  • Hiroshima University
  • Ministry of Health, Labour and Welfare, Japan

Registry information

Official study title

Secondary Prevention With HMG-CoA Reductase Inhibitor Against Stroke

Important dates

Study start
2004
Primary completion
2014
First posted
Sep 22, 2005
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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